Clinical Research Project Manager — Biomedical Coordinator: The Clinical Research Project Manager manages all activities associated with biomedical and social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; and multi-million dollar budgets. The position ensures completion of contract requirements and client specifications. The Clinical Research Project Manager oversees day-to-day operations including identifying and securing needed resources; creating, implementing, monitoring, and updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones and goals are attained; monitoring and reporting progress as appropriate; and resolving or escalating issues in a timely manner. The position may co-author scientific papers for presentation and publication and coordinates writing, submission and administration of grants. The Clinical Research Project Manager ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy and procedure developed by the NU Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).
Project Description: RADAR, a new NIH/NIDA-funded longitudinal study, will build a dynamic dyadic-network cohort of young men who have sex with men (YMSM) by hybridizing existing cohorts of YMSM and enrolling their romantic partners into the study. The goal of this project is to apply a ‘next generation’ multilevel model to understand the syndemics of drug use and HIV-related health behaviors among a large cohort of YMSM (age 16-29) and inform ‘high-impact’ HIV prevention with this vulnerable population. Multiple longitudinal observations of biological, individual, dyadic, and network data will be collected and analyzed.
Position Responsibilities: The Clinical Research Project Manager’s primary activities will involve managing the biomedical specimen collection and biomedical protocols for the RADAR study. The position’s specific activities include: providing HIV counseling, testing, and referral services; building relationships with social services and medical services for referrals; overseeing staff certifications and trainings related to lab safety, phlebotomy lab certification and specimen collection and handling; performing blood draws; conducting study assessments, as needed.
May assist in hiring and managing phlebotomy-trained staff. Some evening and weekend hours may be required.
• Plans, develops and implements new processes and protocols to support research studies and maximize or extend study capabilities;
• Oversees completion of study activities per protocol.
• Collaborates with nursing staff and Principal Investigator (PI) to ascertain pretreatment and eligibility requirements;
• Interviews participants and obtains social and medical histories; based on results determines and registers participants with appropriate sponsors;
• Completes informed consent; determines and organizes patient’s treatment and test schedules;
• Ensures that study protocols are in compliance with appropriate rules and regulations and reviews study progress and recommends revisions, amendments, and other study changes as necessary to better meet needs of sponsors;
• Reviews scientific literature and evaluates and recommends applicable techniques and procedures;
• Acts as liaison between sponsoring agencies, collaborating organizations and other research and educational institutions;
• Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws and research protocols are completed in a timely manner;
• Manages project data including processing, accuracy, analysis and evaluation of data ensuring that results meet project information and deliverable objectives;
• Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports;
• Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data;
• Monitors accounts.
• Negotiates prices and specifications with vendors;
• Purchases supplies, materials, equipment and services;
• Ensures appropriate allocation and compliance;
• Trains, directs, assigns duties to and may supervise lab EEs, students, residents and fellows;
• Acts as a mentor in regard to education of junior coordinators;
• Performs other duties as assigned.
• A bachelor’s degree in a social or health science and 5 years’ experience; or 7 years practical research study or related experience; or a master’s degree in a social or health science and 3 years’ experience or the equivalent combination of education and experience from which comparable knowledge and abilities can be acquired;
• Supervisory or project management experience required;
• Must complete NU’s IRB CITI training before interacting with any participants and must re-certify every 3 years.
• A professional degree in healthcare and clinical/medical laboratory management, or similar training/experience in clinical research in a medical setting;
• Phlebotomy certification and experience in managing point-of-care laboratory testing of FDA-waived testing or laboratory testing classified as moderately complex;
• Certification in safe shipping guidelines (DOT/Hazardous materials), universal precautions for collection and handling of biospecimens that may contain bloodborne pathogens;
• Certification in HIV testing and counseling in Illinois;
• Experience setting up clinical guidelines, CLIA certification, and maintaining COC and Certificate of Waiver in Illinois;
• Experience in clinical and longitudinal research projects;
• Experience working with LGBT youth;
• Experience working in non-profit, community-based settings;
• Strong project management skills and the ability to prioritize tasks;
• Efficient and resourceful in problem-solving and developing biomedical SOPs, lab manuals, and clinical research guidelines for the collection, processing, and shipping of biospecimens;
• Good communication skills; demonstrated effectiveness in spoken and written communication;
• Demonstrated ability to take ownership of work and follow-through on multiple projects;
• Willing to learn new skills, such as point-of-care diagnostic HIV testing and urine drug screening
• Knowledge of HIV and HIV risk among young men who have sex with men;
• Knowledge of CLIA certification requirements, compliance and accreditation standards.
To Apply: Visit the Northwestern Career Resource locator and search for Job ID 23786. Applications should include a CV and cover letter explaining fit with this position, research experience, career goals, and the names of two references. Consideration of applications will begin immediately and continue until the position is filled. As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes including veterans and individuals with disabilities.
Date Posted: 8/15/2014
Postdoctoral Scholar in LGBT Youth Health Disparities
This Postdoctoral Scholar position will be jointly funded by Drs. Michael Newcomb and Brian Mustanski and will focus broadly on examining health disparities in LGBT youth populations, with an emphasis on HIV risk and substance use in young men who have sex with men (YMSM). The Scholar will have the opportunity to conduct data analysis, prepare manuscripts, participate in grant writing activities, and learn about intervention development and implementation. The Postdoctoral Scholar position is not tied to a specific research grant; rather, the Scholar and mentors will work together to select training opportunities based on the mutual needs. Example projects include a NIH/NIDA-funded sexual diary study of substance-using YMSM (R03DA035704), a NIH/NIDA-funded longitudinal cohort study of YMSM and their serious romantic partners that incorporates dyadic, social network, and biomedical data (U01DA036939), and a Northwestern-funded healthy relationships program for young same-sex male couples. The IMPACT Program will also make available data from previous studies of various LGBT youth populations for analysis and manuscript preparation. Dr. Newcomb will serve as the primary mentor (Dr. Mustanski secondary mentor) for this position. Opportunities will be available for collaboration with other IMPACT Program faculty and faculty collaborators.
Keep It Up! (KIU!) Postdoctoral Scholar
This NIH/NIDA funded study (1R01DA035145) is led by Brian Mustanski, Ph.D., Director of the IMPACT Program at Northwestern University. The Keep It Up! 2.0 (KIU! 2.0) project is a multisite randomized control trial (RCT) comparing two versions of an online HIV prevention program for young men who have sex with men (YMSM). KIU! 2.0 is being conducted in collaboration with researchers at Hunter College in New York City (site lead Jeff Parsons of CHEST) and Emory University in Atlanta (site lead Patrick Sullivan of PRISM). The Postdoctoral Scholar will be responsible for overall project management of the multi-site study, including: a) managing the research team consisting of research assistants, data manager(s), and interns; b) managing IRB protocols at Northwestern University; c) monitoring recruitment and retention efforts in Chicago, Atlanta, and New York and troubleshooting challenges; d) preparing reports, including NIH grant progress reports and DSMB reports; e) planning and facilitating project meetings; and f) participating in the writing of manuscripts and conference presentations. Dr. Mustanski will serve as the primary mentor with opportunities for interaction and collaboration with IMPACT Program faculty and faculty collaborators.
Postdoctoral Scholar in Network Influences on HIV
This NIH/NIDA-funded study (U01DA036939; PI: Mustanski) will build a dynamic dyadic-network cohort of young men who have sex with men (YMSM) by hybridizing existing cohorts of YMSM. The goal of this project is to apply a “next generation” multilevel model to understand the syndemic of health problems among a large cohort of YMSM (age 16-29) and inform “high-impact” HIV prevention with this vulnerable population. Multiple longitudinal observations of biological, individual, dyadic, and network data will be collected and analyzed. The Postdoctoral Scholar will assist the Network Science Working Group of the U01 study, including: a) collaborating on the design, beta testing, and implementation of a touch-screen network capture measure to be implemented; b) leading the development and execution of a network data management system; c) monitoring the integrity of network data; and d) participating in the dissemination of findings through publications and conference presentations. The Postdoctoral Scholar will be mentored by Drs. Michelle Birkett and Noshir Contractor, co-leads of the Network Science Working Group. Dr. Birkett is a Research Assistant Professor within the IMPACT Program in the Department of Medical Social Sciences. Dr. Contractor is the Jane S. & William J. White Professor of Behavioral Sciences and the Director of the Science of Networks in Communities (SONIC) Research Group at Northwestern University. The Postdoctoral Scholar will play an important role uniting SONIC and IMPACT in this highly interdisciplinary project.
Environment: The IMPACT Program is based in the Department of Medical Social Sciences in the Feinberg School of Medicine at Northwestern University. The mission of the IMPACT Program is to conduct translational research that improves the health of the LGBT community and to develop the research capacity of the community. It was founded by Dr. Mustanski in 2008 and has been the home to many federal- and foundation-funded research projects. The IMPACT Program’s multidisciplinary team includes 6 doctoral-level scientists, multiple masters-level staff, and a team of data managers and research assistants.
The Science of Networks in Communities (SONIC) Research Group, led by Dr. Contractor, advances social network theories, methods, and tools to better understand and meet the needs of diverse communities. SONIC is a leader in developing cutting-edge techniques to study and improve social and knowledge networks in distributed working groups, online communities, virtual teams, and other large communities. Using a comprehensive methodology, SONIC researchers model, assess, validate, and enable the emergence of social and knowledge networks. The Group consists of multiple faculty, programmers, postdocs, students, and a full-time associate director.
Postdoctoral Scholars will be based in the Department of Medical Social Sciences, which provides a unique home for applied researchers who integrate biomedical and social science approaches to improvement of health. Its defining features are an emphasis on interdisciplinary research and a strongly collaborative orientation. The department provides rich resources for conducting research, including a broad scientific portfolio with multiple, well-characterized cohorts across the lifespan, psychometric/biostatistical and health informatics cores, expertise in multi-level assessment methods and collaborative relationships across Northwestern’s biomedical and social sciences campuses.
Stipend and benefits: Compensation for this Postdoctoral Scholar position takes into account NIH salary guidelines.The appointment will come with the commensurate benefits offered for this position at Northwestern.
Eligibility: Completion of the doctorate prior to the start of the position is required for both positions.
LGBT Youth Health Disparities: Candidate will have a doctorate in the social/behavioral/health sciences. Additional academic interests in LGBT health, HIV prevention, eHealth interventions, and clinical research are preferred.
KIU!: Candidate will have a doctorate in the social/behavioral/health sciences and must have experience in research project management. Additional academic interests in LGBT health, HIV prevention, eHealth interventions, and clinical research are preferred.
Networks: Candidate will have a doctorate in the social/behavioral/health sciences or a related field. The candidate must have experience in social network science and quantitative methods as well as an interest in applications to health domains. Additional academic interests in HIV prevention/transmission, LGBT health, Sexual Networks, Computational Social Science, and Modeling Dynamic Networks are preferred. Additionally, experience with large linked data management and graph database programming is welcome.
To apply: Applications should include a CV and cover letter explaining fit with this position, research experience, career goals, and the names of two references. Consideration of applications will begin immediately and continue until the position is filled. Northwestern University is an Affirmative Action/Equal Opportunity Employer. Applications from women and minorities are encouraged.
LGBT Youth Health Disparities: should email application materials to Dr. Newcomb (firstname.lastname@example.org)
KIU! Applicants: should email application materials to Dr. Mustanski c/o Ryan Coventry (email@example.com).
Network Applicants: should email application materials to Dr. Birkett (firstname.lastname@example.org).
Our Training page contains information about the clinical psychology internship track in LGBT health with the IMPACT Program, as well Northwestern University’s Health Sciences Integrated PhD Program.
Please visit our Internships page for a full listing of film, web, writing/blogging, and research assistant internship opportunities.
IMPACT Program Diversity Statement: Northwestern University and IMPACT’s commitment to diversity is critical to our mission of advancing access to excellence in academic programs, world-class research, and health programs. Engagement in discrimination or harassment against any person because of race, color, sex, religion, national origin, ancestry, age, marital status, military service, disability, sexual orientation, and gender identity or expression will not be tolerated. Through its work, the IMPACT Program advances the health and wellbeing of LGBT individuals. Staff and trainees should expect to find a diversity of sexual orientations and gender identities among IMPACT staff, trainees, research participants, and in outreach experiences. We highlight the importance of respecting and valuing this aspect of diversity among staff and trainees.